A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis
In brief
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants with Gastroparesis (GP).
Key facts
- Study ID
- NCT03268941
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 51
- Starts
- 2017-09-26
- Expected to finish
- 2018-03-09
- Last updated by the study team
- 2021-01-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- In order to be eligible for participation in this trial, the participant must:
- Has a documented diagnosis of diabetes mellitus gastroparesis (DG) or idiopathic gastroparesis (IG).
- Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 40 kilogram per square meter (kg/m\^2) at the Screening Visit.
- Be a non-smoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months prior to trial drug administration of the initial dose of trial drug/invasive procedure.
- Has symptoms for gastroparesis (GP) (that is, chronic postprandial fullness, abdominal pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) the past 3 months.
- Has documented slow gastric emptying (GE), with delayed GE by 13C-Spirulina gastric emptying breath test (GEBT) at Screening defined as >=80th percentile. Note: If a participant has had a documented scintigraphy or GEBT within the last 12 months that confirms the diagnosis of delayed GE, a screening GEBT would not be required.
- Has nausea subscale (of American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary [ANMS-GCSI-DD]) symptom score >=2 at least 3 of 7 days during Screening.
- Has haemoglobin A1c (HBA1c) less than (<) 10 percent (%) (for diabetes mellitus only).
You may not qualify if…
- The participant must be excluded from participating in the trial if the participant:
- Has acute severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, gastric pacemaker, chronic parenteral feeding or persistent severe vomiting.
- Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism, and pulmonary function.
- Has a history of anorexia nervosa or bulimia.
- Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
- Difficulty swallowing solid food or pills.
- Prior surgery involving the luminal gastrointestinal (GI) tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed greater than (>) 3 months prior to SmartPill test).
- Any abdominal or pelvic surgery within the past 3 months.
- Known or history of inflammatory bowel disease.
- Has active diverticulitis, diverticular stricture, and other intestinal strictures.
- Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks prior to the pretrial (screening) visit milligram per deciliter (mg/dL) (14.99 millimole per liter [mmol/L]) during any visit up to and including the randomization visit (Period 1 Day 1 predose). Note: If the participant meets this exclusion criterion and the investigator believes that the value is not consistent with the participant's current self-monitoring blood glucose values, the participant should not be excluded at this time. The visit can be repeated within 5 to 7 days.
- Has had diabetic ketoacidosis (within the prior 4 weeks).
Where it is running
- 9171 West Thunderbird Road — Peoria, Arizona, United States
- 850 North Kolb Road — Tucson, Arizona, United States
- 11219 Financial Centre Parkway — Little Rock, Arkansas, United States
- 13055 Southwest 42nd Street — Miami, Florida, United States
- 8200 Southwest 117th Avenue — Miami, Florida, United States
- 125 Clairemont Avenue — Decatur, Georgia, United States
- 616 South Washington Street — Bastrop, Louisiana, United States
- 6035 Shallowford Road — Chattanooga, Tennessee, United States
- 26 Stonecreek Circle — Jackson, Tennessee, United States
Full record on ClinicalTrials.gov
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